Class II · ModerateRecall completed
Ranitidine 150 mg tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberP134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021
Where it was soldProduct was distributed to one consignee who may have distributed the product further to their retail stores.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | AAA Pharmaceutical, Inc. |
| NDC | 37808-196-01 |
Show the full FDA record
| Full product label | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. |
| Recalling firm | AAA Pharmaceutical, Inc. |
| Distribution | Product was distributed to one consignee who may have distributed the product further to their retail stores. |
| Quantity | 34,272 (24-count bottles) |
| Recall initiated | 2019-12-26 |
| Report date | 2020-01-15 |
| Recall completed | 2021-03-10 |
| Recall number | D-0645-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Lumberton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.